Young broilers nibble feed at a chicken farm in Luling, Texas. The Food and Drug Administration has issued new guidance on how drug companies label antibiotics for livestock.

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Originally published on December 11, 2013 6:07 pm

If drug companies follow guidance issued Wednesday by the Food and Drug Administration, within three years it will be illegal to use medically important antibiotics to make farm animals grow faster or use feed more efficiently.

The FDA's announcement wasn't a big surprise; a draft version of the strategy was released more than a year ago.

The bigger news is that the two biggest veterinary drug companies, Elanco and Zoetis, said Wednesday that they will, in fact, follow the FDA's advice and make it illegal for farmers to use their drugs for growth promotion. The Animal Health Institute, which represents most of the industry, likewise expressed enthusiastic support for the FDA's move.

Wednesday's announcement is the latest step in a long-running, sometimes convoluted effort by the FDA to reduce the use of antibiotics in agriculture. As we've reported in our series Pharmed Food, public health advocates are concerned that livestock producers' widespread use of antibiotics could lead to more drug-resistant bacteria, first in animals and eventually infecting people. They're especially concerned about the industry's practice of giving animals low doses of the drugs when they're not sick to make them put on weight faster. Those low doses are more likely to create resistance than high doses for animals that are sick, they argue.

In the newly official guidance, the FDA is hoping to reduce the "subtherapeutic" use by revising drug labels, which define the legal uses of each drug. The FDA is asking companies to remove "growth promotion" or "feed efficiency" as a legal use of any drug that is also used in human medicine. If those uses do not appear on the label, farmers can no longer legally use the drug for them.

The label changes are supposed to happen within three years. Companies have 90 days to say whether they intend to do this or not.

The FDA's announcement inspired diverse reactions. The Animal Health Institute, which has downplayed the risks of farm antibiotic use, promised to support the FDA's initiative — in part for public relations reasons. The AHI's Richard Carnevale told reporters in a conference call that it could help to dispel the common, but incorrect, belief that growth promotion accounts for most antibiotic use in agriculture. He says that most antibiotics are used to prevent or treat disease.

It's impossible to know how many of the antibiotics that farmers use are for growth promotion. The government doesn't collect that information.

Some critics of antibiotic use on the farm condemned the FDA strategy for not going far enough. The Natural Resources Defense Council called it "a free pass to industry" because it relies on voluntary cooperation, rather than binding regulations. The Johns Hopkins Center for a Livable Future predicted that the relabeling exercise will fail to reduce antibiotic use because farmers may just continue to give animals the drugs at low doses for "disease prevention" instead.

Other public health advocates were cautiously optimistic. Laura Rogers, who directs the Pew Charitable Trusts' human health and industrial farming campaign, called it a promising start.

Veterinarians will play a key role in enforcing the new labels and making sure that antibiotics aren't used to promote growth under the guise of disease prevention. They also may be required to sign off on all uses of medically important drugs, if another draft regulation released Wednesday is adopted.

Currently, many of these drugs, such as tetracycline, are available over the counter for farm animals. If the FDA caught a veterinarian prescribing these drugs for growth promotion purposes, that veterinarian could lose his or her license.

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From NPR News, this is ALL THINGS CONSIDERED. I'm Melissa Block.

AUDIE CORNISH, HOST:

And I'm Audie Cornish.

Within three years, farmers will no longer be allowed to give animals antibiotics to make them grow faster or use feed more efficiently. At least that's the plan announced today by the Food and Drug Administration. Now, this depends on voluntary action by the drug companies.

And joining me to talk more about this is NPR's Dan Charles. Welcome, Dan.

DAN CHARLES, BYLINE: Nice to be here.

CORNISH: So tell us the thinking here behind this FDA action.

CHARLES: So it's been a longstanding concern on the part of the FDA and public health advocates. There a lot of antibiotics are used in agriculture on poultry, cattle, pigs. And they're used in many different ways to fight diseases, of course, but also to make them grow faster or just use feed more efficiently. And the fear is the more you use antibiotics, the more you promote the development of drug-resistant bacteria.

So, the FDA is now moving to try to eliminate this one category of use, the use for growth promotion.

CORNISH: And this drug-resistant bacteria, meaning in the animals or in humans?

CHARLES: Well, that's the thing. You would create the drug-resistant bacteria in the animals, but there might be ways for those bacteria to move to humans and infect humans, either on meat or just through the environment somehow.

CORNISH: All right, so why not just ban it altogether? I mean, they're trying to get drug companies to eliminate this voluntarily?

CHARLES: Right. So this is a kind of an interesting commentary on the American regulatory system. The FDA is saying it would just take too long to make this change as a regulation. It could be challenged in court. Industry could sort of tie up for years and years. They're saying this voluntary approach is actually faster and, therefore, more effective.

So what they're doing is issuing a document they call Guidance to Industry. It calls on drug companies to change the labels on the antibiotics that they sell. For any antibiotic that's medically important in humans, the drugs would no longer list growth promotion or feed efficiency on the label as a permissible use; the plan is now the should happen in three years. So companies have 90 days to say whether they will actually do this.

The two biggest drug companies say they will and the industry association says it supports this.

CORNISH: So who would actually enforce this?

CHARLES: The people who would actually be on the ground, supposed control this, are the veterinarians. Right now, a lot of these antibiotics, farmers can just buy them over-the-counter; buy them and mix them into the feed. But the FDA is now moving to make all medically important antibiotics essentially prescription only. Farmers would only be able to get them and use them if a veterinarian signs off on it.

So the veterinarians are supposed to make sure this happens as, you know, according to the label. And if, I suppose, if the FDA caught a veterinarian who is violating this, the veterinarian could lose his or her license.

CORNISH: But help us understand here. I mean, will this really actually reduce antibiotic use in animals?

CHARLES: Honestly, whether this will be effective, I think remains to be seen for the following reason. Many of these same antibiotics can be used for growth promotion or for what's called disease prevention. Basically, if a farmer with a veterinarian thinks that animals are at risk of getting sick, he could still use the drugs.

So here's the question that a lot of people are wondering. Are farmers and veterinarians out across the country going to try to get around this? You know, just use the drugs the same old way and call it disease prevention. Because honestly I think they could, if they really wanted to. Or are they really committed to using as few drugs as possible?

And I've met farmers and veterinarians, some are very committed to reducing drug use and others are pretty cynical about these regulations. So it remains to be seen.